NAPROXEN ENTERIC COATED TABLETS 500MG

Active substance: NAPROXEN

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

NYCOPREN 250 mg & 500 mg
ENTERIC-COATED TABLETS
Naproxen
Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Nycopren is for
2. Before you take Nycopren
3. How to take Nycopren
4. Possible side effects
5. How to store Nycopren
6. Further information

1. WHAT NYCOPREN IS FOR
The name of this medicine is Nycopren. Nycopren contains
the active substance Naproxen. Naproxen is a NonSteroidal Anti-Inflammatory Drug (NSAID) used to reduce
pain and swelling in joint, bone or muscle diseases (e.g.
rheumatoid arthritis, osteoarthritis, gout, ankylosing
spondylitis or musculoskeletal disorders).
If you are not sure why you have been prescribed these
tablets then please ask your doctor.

2. BEFORE YOU TAKE NYCOPREN
Do not take Nycopren
• If you are allergic to naproxen or any of the other
ingredients in the tablets (listed in section 6 of this
leaflet)
• If you are allergic to other NSAIDs
(e.g. ibuprofen, aspirin)
• If you have or have had a serious heart condition
• If you are in the last three months of your pregnancy
• If you have or have had an ulcer or bleeding in the
stomach or intestines
• If you have or have had problems with your liver or
kidneys.
Take special care with Nycopren
Tell your doctor before you take this medicine if you
• are planning a pregnancy or are having problems
becoming pregnant, as Nycopren may make it more
difficult to become pregnant
• are elderly, have ulcerative colitis or Crohn’s disease,
as there is a higher risk of stomach problems (e.g.

ulcers or bleeding)
• have blood clotting problems or are taking medicines to
stop your blood clotting
• have asthma or have had a skin rash, facial
swelling or a blocked or runny nose after taking
another NSAID
• have been told that you have Systemic Lupus
Erythematosus (a condition where your immune
system attacks itself).
Medicines such as Nycopren may be linked to a small
increased risk of heart attack or stroke. Any risk is more
likely with high doses or prolonged treatment. Do not
exceed the recommended dose or duration of treatment.
If you have heart problems, previous stroke or think that
you might be at risk of these conditions (e.g. if you have
high blood pressure, diabetes or high cholesterol or are a
smoker) you should discuss your treatment with your
doctor or pharmacist.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have
recently taken, any other medicines, even medicines
bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking
any of the following medicines, as they may affect how
Nycopren works:
• Aspirin for pain and swelling or Probenecid to
treat gout
• Methotrexate to treat cancer
• Medicines to stop your blood clotting
• Medicines for high blood pressure or heart failure
• Medicines to suppress the immune system such as
Tacrolimus or steroid hormones
• Medicines called Sulphonamides or Quinolone
antibiotics to treat bacterial infections
• Lithium for mental health problems
• Phenytoin for epilepsy
• Medicines to increase urine production
• Mifepristone for abortion.
If you go into hospital or have treatment for other
conditions, tell the doctor that you are taking Nycopren.
Taking Nycopren with food and drink
You can take these tablets with or after food.
Pregnancy and breast-feeding
Do not take Nycopren if you are in the last three months of
your pregnancy. Avoid these tablets if you are in first six
months of your pregnancy or if you are breast-feeding
unless your doctor has advised you to take them.
Driving and using machines
Nycopren may cause headaches, tiredness, problems with
your vision or difficulty sleeping. If affected do not drive or
operate machinery.
Important information about some of the ingredients
of Nycopren
If you know you have an intolerance to lactose contact
your doctor before taking Nycopren.

3. HOW TO TAKE NYCOPREN
Always take Nycopren exactly as your doctor has told you.
Do not crush or chew the tablets. Swallow them whole with
a glass of water.
Dosage
Your doctor will decide your dose, as it depends on your
condition.
Adults:
Rheumatoid arthritis, osteoarthritis and ankylosing
spondylitis - Typical dose is 500-1000 mg twice a day at
12 hour intervals.
Severe night-time pain and morning stiffness - Typical
dose is 750-1000 mg per day.
Gout - Typical dose is 750 mg then 250 mg every 8 hours
until the attack has passed.
Musculoskeletal disorders - Typical dose is 500 mg then
250 mg every 8 hours. Maximum daily dose is 1250 mg.
Elderly and patients with kidney problems: Require
smaller doses. Follow your doctor’s advice.
Children over 50 kg:
Rheumatoid arthritis - Typical dose is 500-1000 mg twice
a day at 12 hour intervals.
If you take more Nycopren than you should
Contact your doctor or pharmacist immediately. Show
them the package.
If you forget to take Nycopren
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for the
one you have missed.

4. POSSIBLE SIDE EFFECTS

BEFORE YOU
Like all medicines, Nycopren can cause side effects,
although not everybody gets them.
Medicines such as Nycopren may be linked to a small
increased risk of heart attack or stroke.
Common side effects: headache; dizziness; vomiting;
nausea; aches and pains in the stomach area;
constipation or diarrhoea; gas or heartburn; ulcers or
bleeding in the stomach or intestines.
If you vomit blood or have blood in your stools, stop taking
the tablets and tell your doctor.
Rare side effects
Allergic reactions, which may cause asthma; difficulty
breathing; itching; rashes; blistering or skin peeling;
swelling of eyelids, lips, throat, hands, feet or ankles; or
sensitivity to sunlight.
Kidney disease, which may cause swelling of the face and
ankles; or blood in your urine.
Liver disease, which may cause yellowing of the skin and
whites of the eyes (jaundice).
Infection in the fluid of your spine or brain (meningitis),

which may cause stiff neck; headache; vomiting; nausea;
fever; depression; disorientation; confusion; nervousness;
ringing in the ears; mouth ulcers; an inflamed pancreas or
difficulty breathing, concentrating or sleeping.
Reduction in red blood cells (anaemia), which can make
the skin pale and cause weakness or breathlessness.
If any of the side effects become serious, or if you
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.

5. HOW TO STORE NYCOPREN
Keep out of the reach and sight of children.
Store in the original container and keep the container
tightly closed.
Do not use these tablets after the expiry date, which is
stated on the package. The expiry date refers to the last
day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6. FURTHER INFORMATION
What Nycopren contains
The active ingredient in Nycopren is naproxen. The other
ingredients are lactose, potato starch, povidone, glycerol,
sodium starch glycollate, magnesium stearate, eudragit L
12.5 and L30D, triacetin, talc, polyethylene glycol and
silicone antifoam.
What Nycopren looks like and contents of the pack
Nycopren 250 mg is a oval white tablet with no markings.
Nycopren 500 mg is a oblong white tablet with a break line
engraved on one side.
The tablets come in blisters packs and containers of 8, 56,
60, 84, 100 and 250 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Chatfield Pharmaceuticals Limited,
Kramer Mews, London SW5 9JL
Manufacturer
Haupt Pharma Berlin GmbH, Gradestraße 13,
Moosrosenstraße 5 and Britzer Damm 120,
12347 Berlin, Germany
DDSA Pharmaceuticals Limited,
310 Old Brompton Road
London SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last approved in 04/2010
NAP0059-60/0250&0500E/LEA005

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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